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Device-Tax Repeal In Doubt As House Postpones Health Bill Vote

US House Republicans canceled a planned vote on the "repeal and replace" American Health Care Act March 23 after failing to secure enough support to ensure passage of the measure. Republicans are still trying salvage a compromise, but the developments threaten industry's goal of achieving a permanent repeal of the medical device tax in the near term.

Policy Legislation Medical Device

New Chronix Liquid Biopsy Test Could Save Doctors On Immunotherapy Costs

Chronix Biomedical continues to demonstrate the potential of its blood-based cancer test across a growing range of indications – this time, its ability to help doctors assess how well patients are responding to immunotherapy, at an earlier stage than current diagnostic imaging methods.

Cancer Innovation Medical Device

Unlocking Legalities: Antitrust Risk Rises In China

A $17.2m fine Chinese regulators imposed on Medtronic may just be the tip of the enforcement iceberg as the country attempts to discipline overseas manufacturers who break new antitrust laws.

China Legal Issues Unlocking Legalities

Compliance 360° Part 7: Factors Feeding Your Inspection Cycle – A New Paradigm

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this seventh installment, former US FDA investigations branch director Ricki Chase explains how new initiatives within the agency and center for devices – including FDA's in-the-works "program alignment" inspection initiative, may affect your facility audits. Also discussed: the Medical Device Single Audit Program (MDSAP), the joint FDA/Medical Device Innovation Consortium (MDIC) Case for Quality, and FDA's Voluntary Compliance Improvement Program (VCIP).

Quality Control Compliance Quality
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Policy & Regulation Explore this Topic

Set Alert for Policy

Drug/Device Combinations: How To Harness Global Regulatory Efficiencies

In this interview, Arkan Zwick, regulatory affairs director at Croma Pharma, talks about the global picture for regulation of device-type drug/device combination products. Regulatory requirements for these products for are among the most demanding and costly. Zwick discusses opportunities to utilize existing testing and maximize efficiencies on a global scale.

Combination Products Regulation Medical Device

CMS Administrator Seema Verma: What Industry Can Expect

The Senate confirmed former health-policy consultant Seema Verma as administrator of the US Centers for Medicare and Medicaid Services earlier this month, and she was sworn in March 14. Medtech Insight took a look at some of Verma's policy positions affecting industry, including potential changes to accountable care organizations, appropriate-use criteria, the Centers for Medicare and Medicaid Innovation, lab payments, and telehealth services.

Reimbursement Legislation Policy

FDA Yields To Pressure, Delays ‘Intended Use’ Rule

The agency has granted a petition from trade groups to delay controversial revisions to its definition of “intended use” for at least one year, and is also gathering comments to guide possible further revisions.

Regulation FDA

Warning Letter Roundup & Recap – March 21, 2017

No device-related warning letters were released by US FDA the week of March 21.

Device Warning Letters Medical Device

Combo Products Won't Get Special Review Pathway At US FDA Anytime Soon

FDA's Jeffrey Shuren and Janet Woodcock tell a Senate committee that the agency is more concerned with implementing combination product provisions from the 21st Century Cures Act than working on a novel review pathway for device/drug combination products.

Combination Products Policy

'Low-Hanging Fruit' Of Industry Comms Policy Addressed By Recent FDA Documents

Draft guidance documents issues by US FDA in January did not tackle the toughest off-label speech debates, but they did provide some useful information to guide company communications, experts said on a recent FDLI webinar.

Regulation Advertising, Marketing & Sales

Number To Know…3

Only three leadless pacemakers have been CE marked to date, as revealed following the publication of recent UK guidelines on how to evaluate such products.

Cardiology Regulation

Risks Of Missing Reauthorization Deadline Highlighted At User-Fee Hearing

FDA center directors, including device chief Jeffrey Shuren, told lawmakers they are committed to reauthorizing user-fee programs during a March 21 Senate hearing. The officials wouldn't comment on a recent budget proposal from the Trump administration that seeks more user fees and less appropriations from Congress that industry agreed to.

Policy Regulation

Quality Control Explore this Topic

Latest From Quality Control

Compliance 360° Part 6: Don’t Do That! How To Respond To FDA-483s

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this sixth installment, former US FDA investigations branch director Ricki Chase explains how your firm can best respond to the agency following the issuance of an FDA-483 inspection form, and tells you four things your firm should never do when replying to FDA.

Quality Control Compliance

Compliance 360° Part 5: Medical Device 483s – US FDA's Top 5 Observations

This is Compliance 360°, an eight-part podcast series from Medtech Insight on US FDA compliance and enforcement issues. In this fifth installment, former FDA investigations branch director Ricki Chase highlights the agency's top 5 inspection observations found on FDA-483 inspection forms, including failing to have procedures for corrective and preventive action (CAPA), complaint handling, purchasing controls, process validation, and nonconforming product.

Quality Control Compliance

US Regulatory Reads, February: Compliance, Gorsuch And Executive Orders

The 10 most popular Medtech Insight stories in February on a US regulatory theme included our Compliance 360° podcast series, continued coverage on the impact of President Trump's executive orders on US FDA oversight, and an assessment of the potential impact of Neil Gorsuch, who has been nominated to fill the opening on the US Supreme Court.

Quality Control Regulation

Commercial Explore this Topic

Set Alert for Commercial

$50m In New Capital Could Help Moximed Spring Into US Earlier

In its latest and biggest fundraising to date, Moximed has bagged $50m in a series C round, which will help the company take its joint-unloading technology for osteoarthritis patients through US approval and into early commercialization.

Orthopedics StartUps and SMEs Financing

Latest From Commercial

Symetis Seeks $60m IPO To Make A Splash In Structural Heart

Symetis, Europe's No. 4 in the TAVR market, hopes its initial public offering, with a price range of €26 to €32 per share on Euronext Paris, will help build on its recent transcatheter mitral valve repair acquisition and its growing market position in TAVR.

Cardiology Financing

Lack Of Monetization Know-How Hits Price Margins For Medtech

One in five medtech companies in Europe feel they are not capable of fully monetizing innovations they are putting out into the marketplace, according to Simon-Kucher & Partner's latest "Medtech Barometer" report. Subsequently, firms are not offsetting losses arising from persistent price erosion, and this is impacting profit growth, the survey findings suggest.

Business Strategies Growth

GE Healthcare Patches In Wireless Fetal Monitoring Device

GE Healthcare has snapped up Novii, a wireless fetal monitoring device, as part of its acquisition of UK-based company Monica Healthcare. GE Healthcare aims to expand distribution of the wireless device, which is currently only available in the US.

Diagnostics M & A

Latest Mako Tech Fleshes Out Stryker's Robotic Joint Replacement Line But Cost Critics Still There

Stryker launched the Mako robotic arm-assisted total knee arthroplasty system at last week's AAOS annual meeting, making the company the first to offer a surgical robotic technology that covers the total knee, partial knee and total hip replacements. Critics, however, say the clinical outcomes do not necessarily justify the costs. Meanwhile, Stryker's orthopedic rivals, Zimmer Biomet and Smith & Nephew, also sought to highlight their own robotic offerings.

Orthopedics Surgery

Device Week – Mar. 17, 2017

On this week's Medtech Insight podcast: President Trump releases budget "blueprint" calling for cuts in many US agencies, including FDA; class II designations formalized by FDA for a slew of important products; FDA proposes exempting from 510(k) requirements hundreds of class II devices; a new surgical robotic project wins a €4m grant from European Commission; an update from the American College of Cardiology annual scientific sessions.

FDA Medical Device

Could The City Hospitals Project Be A Bit Of A Turkey?

As Turkey’s City Hospitals project goes underway, with the first few hospitals already up and running, big medtech players are swooping down to capitalize on this opportunity which promise to boost the Turkish market by up to TRY2bn. However, intense competition, as well as basic problems that had been plaguing companies operating in that country, persists and still needs to be resolved.

Turkey Commercial

Clinical R&D Explore this Topic

Set Alert for Clinical R

ACC 2017: SURTAVI Supports Intermediate-Risk Intervention For Medtronic's CoreValve

In an interview with Medtech Insight, the lead investigator of SURTAVI, an ongoing trial of Medtronic's CoreValve in intermediate risk patents, says transcatheter aortic valve is continuously improving and will probably soon be indicated for even low-risk patients, but that surgical valve replacement will have an important role to play for the foreseeable future.

Cardiology Clinical Trials Research & Development

Latest From Research & Development

ACC 2017: Trial Shows FFR-Guidance Can Help Heart Attack Patients Avoid More Revascularizations

Results of the Compare-Acute trial show that STEMI patients benefit from complete revascularization guided by fractional flow reserve measurement, but most of this benefit was driven by the reduction in repeat revascularization. Investigators say more research will be needed to determine if this approach can reduce mortality or other "hard" endpoints.

Clinical Trials Research & Development

ACC 2017: Double-Whammy Trial Data Boost For Philips' iFR

Results from the iFR SWEDEHEART and DEFINE-FLAIR trials, both presented at this month's American College of Cardiology Scientific Sessions in Washington, DC, show that coronary revascularization guided by instantaneous wave-free ratio measurement is non-inferior to fractional flow reserve measurement in guiding coronary revascularization

Cardiology Innovation

Acarix's Handheld CAD Device Proves Its Mettle As Frontline Test

The latest clinical data on Acarix's handheld acoustic device, the CADScor system, backs the use of the technology as a frontline test for ruling out coronary artery disease in patients presenting with suspicious chest pain. Results from a multi-center trial showed CADScor achieved a 97% negative predictive value.

Cardiology Diagnostics

Lack Of Monetization Know-How Hits Price Margins For Medtech

One in five medtech companies in Europe feel they are not capable of fully monetizing innovations they are putting out into the marketplace, according to Simon-Kucher & Partner's latest "Medtech Barometer" report. Subsequently, firms are not offsetting losses arising from persistent price erosion, and this is impacting profit growth, the survey findings suggest.

Business Strategies Growth

Pulse Biosciences' Shoots For US Clearance Of Nano-Pulse Platform

Pulse Biosciences' nano-pulse technology, PulseTx, precisely targets and kills cells with short electrical pulses that induce cell death and induce an immunogenic response. The company has submitted a 510(k) application to the US FDA for the technology, seeking a broad soft-tissue ablation indication, but it is developing PulseTx for immunoncology and dermatology indication.

Cancer ImmunoOncology

When Surgical Robotics Become Wearable

A 10-partner research project has won a €4m EU grant to develop a wearable surgical robotic system, the first of its kind. The leader of the project, Sanja Dogramadzi of the Bristol Robotics Laboratory, provided more details on how this new technology would improve on existing systems like Intuitive Surgical's leading da Vinci.

Surgery Innovation
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